ala-hist ir

Generic: dexbrompheniramine maleate

Labeler: poly pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name ala-hist ir
Generic Name dexbrompheniramine maleate
Labeler poly pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexbrompheniramine maleate 2 mg/1

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-783
Product ID 50991-783_4513db4f-e8f2-ecc6-e063-6294a90a1b17
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2011-08-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991783
Hyphenated Format 50991-783

Supplemental Identifiers

RxCUI
2262293 2262295
UPC
0350991783605
UNII
BPA9UT29BS

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ala-hist ir (source: ndc)
Generic Name dexbrompheniramine maleate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (50991-783-02) / 1 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE, PLASTIC (50991-783-60)
source: ndc

Packages (2)

50991-783-02 12 BLISTER PACK in 1 CARTON (50991-783-02) / 1 TABLET in 1 BLISTER PACK 50991-783-60 60 TABLET in 1 BOTTLE, PLASTIC (50991-783-60)

Ingredients (1)

dexbrompheniramine maleate (2 mg/1)

Linked Drug Pages (1)

ALA-HIST IR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4513db4f-e8f2-ecc6-e063-6294a90a1b17", "openfda": {"upc": ["0350991783605"], "unii": ["BPA9UT29BS"], "rxcui": ["2262293", "2262295"], "spl_set_id": ["0d203b5c-8b10-428b-8703-17be6b4ce6eb"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (50991-783-02)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "50991-783-02", "marketing_start_date": "20110822"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (50991-783-60)", "package_ndc": "50991-783-60", "marketing_start_date": "20110822"}], "brand_name": "ALA-HIST IR", "product_id": "50991-783_4513db4f-e8f2-ecc6-e063-6294a90a1b17", "dosage_form": "TABLET", "product_ndc": "50991-783", "generic_name": "Dexbrompheniramine Maleate", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ALA-HIST IR", "active_ingredients": [{"name": "DEXBROMPHENIRAMINE MALEATE", "strength": "2 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110822", "listing_expiration_date": "20261231"}